# K221275: Qraycam PRO

- Pathway: 510(k) (Traditional)
- Applicant: AIOBIO Co., Ltd.
- Decided: Sep 4, 2024 after 856 days
- Product code: NBL (Light-Induced Fluorescence Caries Detector )
- Device class: 2
- Regulation: 21 CFR 872.1745
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN990002 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040063: Inspektor Pro, Inspektor Dental Care BV (2004) Summary page 5.

## Indications for use
The Qraycam PRO is intended to be used as an aid in the diagnosis of dental caries.

Source page: https://510kreport.com/device/K221275
Methodology: https://510kreport.com/methodology